NCT00677170已完成1 期
An Open-Label, Dose Escalation, Phase I Study of MLN4924, a Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients With Nonhematologic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 3
- 主要终点
- Determine the safety profile, MTD and PK/pharmacodynamics of MLN4924
研究概览
简要总结
This study is an open-label, multicenter, Phase 1, dose escalation study of MLN4924 in adult patients with nonhematologic malignancies. This study will be the first to administer MLN4924 in humans. The patient population will consist of adults with any form of nonhematologic malignancy for which standard, curative, life prolonging, or palliative treatment does not exist or is no longer effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18 years or older
- •Eastern Cooperative Oncology Group performance status 0-2
- •Patients must have a diagnosis of a nonhematologic malignancy for which standard curative, life-prolonging, or palliative treatment does not exist or is no longer effective.
- •Expected survival longer than 6 weeks from enrollment in the study
- •Radiographically or clinically evaluable tumor
- •Suitable venous access for the conduct of blood sampling for MLN4924
- •Tumor tissue that, in the opinion of the investigator, can be safely biopsied using a core needle
- •Male patients must use an appropriate method of barrier contraception
- •Female patients must be postmenopausal, surgically sterilized, or willing to use reliable methods of birth control
- •Voluntary written consent
排除标准
- •Pregnant or lactating
- •Major surgery within 14 days prior to the first dose of study treatment
- •Serious infection within 14 days prior to the first dose of study treatment
- •Receiving antibiotic therapy within 14 days prior to the first dose of study treatment
- •Life-threatening illness unrelated to cancer
- •Diarrhea that is greater than Grade 1 in severity
- •Systemic antineoplastic therapy within 21 days preceding first dose of study treatment
- •Radiotherapy within 21 days preceding first dose of study treatment
- •Prior treatment with radiation therapy involving ≥25% of the hematopoietically active bone marrow
- •CYP3A inducers within 14 days before the first dose of MLN
- •Moderate and strong CYP3A inhibitors and CYP3A inducers are not permitted during the study.
- •Clinically significant central nervous system metastases
- •Absolute neutrophil count <1,500/mm3; platelet count <100,000/mm3
- •Patients with a prothrombin time or aPTT > 1.5 x the upper limit of the normal range, or with a history of a coagulopathy or bleeding disorder
- •Ongoing anti-coagulant therapy that can not be held to permit tumor biopsy
- •Calculated creatinine clearance <50 mL/minute
- •Bilirubin >1.5 times the upper limit of normal; aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase >2.5 times the upper limit of normal.
- •Uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months
- •Abnormalities on 12-lead electrocardiogram including, but not limited to, changes in rhythm and intervals that in the opinion of the investigator are considered to be clinically significant
- •Known human immunodeficiency virus positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
- •Treatment with any investigational products within 28 days preceding the first dose of study treatment
研究组 & 干预措施
1
Experimental
MLN4924
干预措施: MLN4924 (Drug)
结局指标
主要结局
Determine the safety profile, MTD and PK/pharmacodynamics of MLN4924
时间窗: Maximum duration of therapy for 12 months
次要结局
- Disease response(Day 21, every other cycle and end of study)
研究者
研究点 (3)
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